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Recruiting

The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease

Asset

Lecanemab

Listed sites

1

Recruiting sites

1

Enrollment

120

estimated

Study population

Alzheimer’s disease

Key I/E criteria

Amyloid biomarker required (PET/CSF)MMSE ≥20Study partner/caregiver requiredMRI contraindications excludedHistory of intracranial hemorrhage excluded

Primary endpoint

Resting-state fMRI brain network metrics

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDKS2024354
NCT IDNCT06871839

Timeline

Milestones

Study start2025-03-10actual
Study first posted2025-03-12actual
Last update posted2025-07-22actual
Primary completion2026-12-31estimated
Study completion2026-12-31estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age between 50 and 90 years.

2. Male or female patients.

3. Patients with MCI and mild AD.

4. MMSE score ≥20, CDR overall score of 0.5 or 1.

5. Amyloid-positive confirmed by Amyloid-PET or CSF.

6. Have a reliable caregiver to accompany the patient during study visits and supervise the use of study medication during the trial.

7. Agree to participate in the study and sign the informed consent form

Exclusion criteria

1. Patients with cognitive impairment due to reasons other than AD.

2. A history of transient ischemic attack (TIA), stroke, cerebral hemorrhage, or seizure within the 12 months prior to screening.

3. A score of >17 on the Hamilton Depression Scale at screening, or any suicidal behavior within 6 months prior to screening, at screening, or at the baseline visit, as well as any psychiatric diagnosis or symptoms that interfere with the study procedure (such as hallucinations, anxiety disorder, or paranoia).

4. Patients with a bleeding disorder or receiving anticoagulant therapy, as well as any with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine, and cardiovascular system diseases that affect this study.

5. A hypersensitivity reaction to ranucimab or any other ingredient in the injection solution, or to any monoclonal antibody treatment.

6. Contraindications to MRI scanning, including those with a pacemaker/defibrillator or ferromagnetic metal implants (except for skull and cardiac devices approved as safe for MRI scanning).

7. A known or suspected history of drug or alcohol abuse or dependence within the 2 years prior to screening.

8. Participation in a clinical study involving any therapeutic monoclonal antibody or novel compounds for the treatment of AD within the 6 months prior to screening, unless it can be proven that the subject was in the placebo treatment group.

9. Planning to undergo surgery requiring general anesthesia during the study period.

10. A positive pregnancy test result, lactation, or pregnancy in females at screening or baseline.

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition
4
Behavior / neuropsychiatric
4
Neuroimaging
4
Function / daily living
2
Amyloid biomarkers
2
Caregiver / quality of life
2
Other (unclassified)
2
Neurodegeneration biomarkers
1

Global cognition

4 endpoints
Secondary/protocol endpoint

Rate of change in global cognition as measured by Clinical Dementia Rating (CDR)

Time frame:2 years

change from baseline, improvement

Secondary/protocol endpoint

Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog)

Time frame:2 years

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE)

Time frame:2 years

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA)

Time frame:2 years

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Function / daily living

2 endpoints
Secondary/protocol endpoint

The Integrated Alzheimer's Disease Rating Scale (iADRS)

Time frame:2 years

ADAS-Cog

descriptive

Secondary/protocol endpoint

Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL)

Time frame:2 years

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

4 endpoints
Secondary/protocol endpoint

Five Levels Five-Dimensional Health Scale (EQ-5D-5L)

Time frame:2 years

descriptive

Secondary/protocol endpoint

Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI)

Time frame:2 years

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Hamilton Anxiety Scale (HAMA)

Time frame:2 years

ratio, descriptive

Secondary/protocol endpoint

Hamilton Depression Rating Scale (HAMD)

Time frame:2 years

descriptive

Amyloid biomarkers

2 endpoints
Secondary/protocol endpoint

Blood AD molecular pathology and synaptic structural protein content indicators

Time frame:2 years

Phosphorylated tau 217 (p-tau217)

concentration, descriptive

Secondary/protocol endpoint

Neuroimaging biomarkers: Aβ-PET centiloid values

Time frame:2 years

Amyloid PET Centiloid

descriptive

Neurodegeneration biomarkers

1 endpoint
Secondary/protocol endpoint

Cerebrospinal Fluid Synaptic Function Protein Content Assessment Indicator

Time frame:2 years

concentration, descriptive

Neuroimaging

4 endpoints
Primary/protocol endpoint

Resting-state fMRI brain network metrics (Independent Component Analysis)

Time frame:2 years

descriptive

Secondary/protocol endpoint

Other resting-state fMRI brain network indicators: functional connectivity (FC)

Time frame:2 years

descriptive

Secondary/protocol endpoint

Other resting-state fMRI brain network indicators: Granger Causality Analysis (GCA)

Time frame:2 years

descriptive

Secondary/protocol endpoint

Other resting-state fMRI brain network indicators: Spectral Dynamic Causal Model (spDCM)

Time frame:2 years

descriptive

Caregiver / quality of life

2 endpoints
Secondary/protocol endpoint

Alzheimer's Disease Quality of Life Scale (QOL-AD)

Time frame:2 years

descriptive

Secondary/protocol endpoint

Zarit Caregiver Burden Interview Scale (ZBI)

Time frame:2 years

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Alzheimer's Disease Composite Score (ADCOMS)

Time frame:2 years

descriptive

Other/protocol endpoint/low confidence

Blood neuron-derived exosome transcriptomics-related indicators

Time frame:2 years

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.